|
Relief Therapeutics Holding SA, a biopharmaceutical company, announces that its collaboration partner, ACER Therapeutics, Inc., has provided an update on commercial launch activities for Olpruva.
Relief Therapeutics entered a collaboration and license agreement with Acer Therapeutics Inc. in March 2021 for the worldwide development and commercialization of Olpruva (sodium phenylbutyrate; ACER-001) for oral suspension for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and maple syrup urine disease (MSUD).
Acer reports that in support of the Olpruva launch in Q2 2023, the company is actively adding resources to establish its commercial and medical affairs presence in the US. As a part of its Olpruva commercialization strategy, Acer has recently introduced its patient support service, Olpruva Navigator by Acer Therapeutics, designed to assist UCD patients with support, access, education and patient adherence to treatment. Representatives will begin accepting prescriptions in late Q2 2023. Acer also reports the company is actively engaged in negotiations regarding access for Olpruva with the major commercial payers and state Medicaid organizations.
According to Acer, the company has established a pricing strategy that reflects its commitment to deliver innovative treatments that are responsibly priced and accessible to those in need. Acer intends to price Olpruva competitively, at a significant discount to the currently available commercial product Ravicti, while implementing predictable pricing that will not increase beyond the rate of inflation. Acer indicated the company also plans to invest a portion of Olpruva revenue back into additional solutions aimed at improving outcomes for UCD patients.
“We are pleased with the significant progress Acer has made toward the commercial launch of Olpruva and excited this new treatment option will soon be available to people living with UCDs,” said Jack Weinstein, chief executive officer of Relief Therapeutics. “Olpruva is an innovative formulation of sodium Phenylbutyrate packaged for the first time in single-dose envelopes, which can help patients, caregivers and their healthcare teams manage UCDs.”
Acer will present data from a survey designed to quantify preferences of healthcare providers for urea cycle disorders (UCDs) at the upcoming 44th Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD), March 18–21 in Salt Lake City. Results from the discrete choice experiment will be available on Acer’s website on Sun., March 19 following the poster presentation by Professor Robert Steiner, M.D., University of Wisconsin School of Medicine and Public Health.
Urea cycle disorders (UCDs) are a group of rare, genetic disorders that can cause harmful ammonia to build up in the blood. Any increase in ammonia over time is serious. Long-term toxic ammonia levels can lead to liver and brain damage, severe ketoacidosis, and can even be fatal when left untreated. Therefore, it is important to adhere to any dietary protein restrictions and have alternative medication options to help control ammonia levels. Non-compliance with current therapies is a major issue due to unpleasant taste and odor and cost of treatment.
On December 22, 2022, the US Food and Drug Administration (FDA) approved Olpruva (sodium phenylbutyrate, ACER-001) for oral suspension as a prescription medicine for use with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).4 Please see Important Safety Information and full Prescribing Information, including Patient Information.
Relief Therapeutics is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety and convenience to benefit the lives of patients living with rare diseases.
|